Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain (SUMMIT-07)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02362672|
Recruitment Status : Completed
First Posted : February 13, 2015
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Chronic Pain||Drug: NKTR-181 BID tablets Drug: Placebo to match NKTR-181 BID tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain|
|Actual Study Start Date :||March 11, 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2017|
NKTR-181 twice daily (BID) tablets
Drug: NKTR-181 BID tablets
NKTR-181 tablets 100-400 mg twice daily (BID)
Placebo Comparator: Placebo
Placebo to match NKTR-181 twice daily (BID) tablets
Drug: Placebo to match NKTR-181 BID tablets
Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
- The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) [ Time Frame: 12 Weeks of randomized double blinded period ]The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
- Responder Analysis Based on Percent Reduction in Pain Intensity [ Time Frame: Screening Baseline through Week 12 ]A responder is defined by the Sponsor as a randomized subject who completes the double-blind Randomized Treatment Period and experiences improvement in the Week 12 Weekly Pain Score from Screening Pain Score. This includes the proportion of responders with at least 30% and at least 50% reduction in pain intensity.
- Patient Global Impression of Change (PGIC): Number of Responders [ Time Frame: Screening Baseline through Week 12 ]The PGIC assesses the change in overall status relative to the initiation of the treatment. The scale measures global change of overall status on a 7-point scale (1 = No change (or condition has got worse), 2 = Almost the same, 3 = A little better, 4 = Somewhat better, 5 = Moderately better, 6 = Better, 7 = A great deal better). The proportion of subjects responding " A great deal better " and "better" was summarized by treatment group.
- Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) [ Time Frame: Screening Baseline through Week 12 ]The MOS Sleep Scale measure sleep parameters contains 12 items. Eleven of them scored using a 5-point response scale and across 5 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Items in each dimension (disturbance, sleep problems index, somnolence, adequacy, respiratory impairments) of sleep are averaged together to create the score for the scale. The range of each sleep dimension is from 0 to 100. Higher score of sleep disturbance, somnolence, sleep indices, and respiratory impairments indicates relatively worse sleep problem, whereas lower scores for sleep adequacy indicate worse sleep problems.
- Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) [ Time Frame: Screening Baseline through Week 12 ]The 12 items of the MOS Sleep Scale measure sleep parameters across 6 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), quantity (1 item), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). One of the 12 items, Sleep quantity, records the actual number of hours slept. Reported here is the sleep quantity.
- Change in Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Screening Baseline through Week 12 ]
The RMDQ contains 24 items that is used to quantify the impact of low back pain on subject's ability to perform daily activities, mood and sleep. The questionnaire consists of 24 statements derived from the Sickness Impact Profile, with the addition of the phrase "because of my back." The questionnaire covers the areas of mobility, self-care, and sleeping.
The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362672